Effects of consumption of the test food on bone mineral density: a randomized, placebo-controlled, double-blind, parallel-group comparison study

UMIN ID: UMIN000056870

Registered date:30/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2025/01/30
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 48 weeks Test food: Collagen peptide Administration: Take one packet (3.5 g) per day with water, tea, or coffee. It may also be dissolved in them before consumption. *If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Duration: 48 weeks Test food: Maltodextrin Administration: Take one packet (3.5 g) per day with water, tea, or coffee. It may also be dissolved in them before consumption. *If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. The measured value of bone mineral density of frontal lumbar spine (total amount) at 48 weeks after intervention (48w)
• Secondary Outcome: 1. The changes and percentage changes from screening (before intervention; Scr) of bone mineral density of frontal lumbar spine (total amount) at 48w 2. The measured values of each item (bone area, bone mineral content, T-score, young adult mean (YAM), and Z-score) of frontal lumbar spine (total amount), and the changes and percentage changes from Scr of them at 48w 3. The measured values of each item (bone area, bone mineral content, bone mineral density, T-score, YAM, and Z-score) of frontal lumbar spine (L1, L2, L3, and L4), and the changes and percentage changes from Scr of them at 48w 4. The measured values of each item (bone area, bone mineral content, bone mineral density, T-score, YAM, and Z-score) of left femur (neck, trochanter, intertrochanteric crest, and total amount), and the changes and percentage changes from Scr of them at 48w 5. The measured values of bone-specific alkaline phosphatase (BAP), total type 1 procollagen N-terminal propeptide (P1NP), and tartrate-resistant acid phosphatase 5b (TRACP-5b)), and the changes and percentage changes from Scr of them, and the logarithmic values of them at 12 weeks after intervention

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: Individuals (who/whose) 1. have osteoporosis 2. have taken medications for osteoporosis 3. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 4. have a pacemaker or an implantable cardioverter defibrillator (ICD) 5. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. receive hormonal therapy 7. are heavy smokers (generally smoking 21 or more cigarettes per day) 8. consume excessive alcohol {generally drinking 60 g or more of pure alcohol per day (3 go of sake, 3 medium bottles of beer (1,500 mL), 2 go of shochu, or about 5 glasses of wine (about 600 mL) at least 6 days per week} 9. eating habits are extremely irregular or lifestyles are irregular due to shift work, night work, or others 10. living environment (such as family or work) may majorly change (such as relocation, job transfer, or long-term travel), or whose eating habits or exercise habits may majorly change during this study 11. are taking "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" (those who take anything that affects bone metabolism (particularly calcium, vitamin D or K, magnesium, or isoflavones (including daidzein, genistein, or equol)) 12. are taking medications (including herbal medicines) or supplements 13. are allergic to medicines or foods related to the test product 14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: JELLICE Co., Ltd.